AKROS BioScience assists its customers in the development of medicines, medical devices, food supplements

MEDICINES

  • Non-Clinical and clinical development plans
  • Common Technical Document
  • Scientific Advice
  • Due diligence of documentation
  • Toxicological and clinical assessment reports

We have experience in a wide range of diseases: in cardiology, diabetology, oncology, neurology, ophthalmology, immunology, with additional specific expertise in the development of biologic treatments.

We draw the Non-Clinical and clinical drug development plans. We design and supervise Non-Clinical and clinical studies; we support our clients in selecting the most suitable Contract Research Organisations (CROs) for their needs and oversight the development of the studies.  We perform the statistical analyses and prepare the study reports. We prepare comprehensive and detailed briefing books for Scientific Advice with national and EU Competent Authorities.

We write the pre-clinical and clinical sections of the Common Technical Documents.

Medicines

Medical Devices

Food Supplement

Non-Clinical and clinical Studies

MEDICAL DEVICES

  • Toxicological assessment of the components
  • Biological and Clinical Evaluation Plans and Reports
  • Risk Analysis
  • Post Market Clinical Follow Up Plans and Reports

We have ten years of experience in preparing the necessary documentation for Medical Device conformity. We have worked with all major Notified Bodies and devices of all risk classes. We support our clients in the classification and regulatory framework of the device.

We prepare Non-Clinical and clinical development plans, designing and supervising clinical investigations, helping our Clients to select the most suitable CROs. We prepare Biological Evaluation Plans and reports, Clinical Evaluation Plans and reports, risk analyses and Post Marketing Clinical Follow Up Plans. We also conduct toxicological and pharmacological assessment of the components of the device

FOOD SUPPLEMENT

  • Safety evaluation
  • Notification documents
  • Documentation for novel food

We have experience in the preparation of pharmacological and toxicological reports on food supplement components. We draw the notification documents required by regulations, and the documentation required by EFSA for novel foods.

NON- CLINICAL AND CLINICAL STUDIES

(medicines, medical devices, food supplements)

  • Design and planning
  • Selection and oversight of the CRO
  • Statistical Analysis
  • Study Reports
We have years of experience in the design of Non-Clinical and clinical studies, choosing the relevant species and defining the most cost-effective experimental designs. We carry out the statistical planning of studies and select the most suitable CROs for our clients’ needs. We supervise the activity of the CRO. We prepare statistical reports and full study reports, identifying the key points of the study and developing the report in accordance with regulations.